| Device Type ID | 1408 |
| Device Name | Mouthguard, Prescription |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MQC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1408 |
| Device | Mouthguard, Prescription |
| Product Code | MQC |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3SHAPE A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERZ DENTAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESMED SAS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SICAT GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 86 |
Patient-Device Incompatibility | 11 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 98 |